Differences Put Aside As ICH Finalizes Guide on Post Approval Changes

Final Q12 Document Adopted At Singapore Meeting Executive Summary An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized. You may also be interested in... Brazil’s pharmaceutical industry has...

Final Q12 Document Adopted At Singapore Meeting

Executive Summary

An international guideline on managing post approval changes to drugs, which was initially criticized because of its incompatibility with legal frameworks in certain ICH regions such as the EU, has been finalized.

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Brazil’s pharmaceutical industry has welcomed the election of medicines regulator ANVISA to the management committee of the International Council for Harmonization.

Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.

Following a report that identified several shortcomings of the European Medicines Agency fee system, the European Commission has suggested various options to make it sustainable and future-proof.

Source: pink.pharmaintelligence.informa.com